This invention relates to medical diagnostic testing.
More particularly, it relates to the collection of vaginal fluids and exfoliated vaginal cells for diagnostic purposes.
Currently, the vast majority of clinical diagnostic testing of biological fluids utilize serum and urine. It is believed that the United States Food and Drug Administration has not approved a clinical diagnostic test which utilizes any biological fluid other than whole blood, serum, plasma, saliva or urine. Tears and sweat are other fluids being used for various non-FDA approved diagnostic purposes, although such uses have been very limited. These fluids are very different in composition and their uses in clinical medicine.
The use of gynecological tissue for cancer diagnostic purposes has been limited to the traditional PAP Test Cervical Scraping (PTCS method of collection) and the subsequent histological smears for cervical cancer screening. A chemical or immunochemical analysis of non-menstrual vaginal fluid, menstrual fluid and/or the cellular extracts of menstrual fluid for the purpose of disease detection or patient well-being have not been exploited by the general medical community.
There have been a number of articles written by Dr. Matthew Freund and others which suggest that one may collect a large quantity of cervical and endometrial cells from menstrual fluids rather than through the traditional PTCS method. Dr. Freund found that both ectocervical and other cells collected from the menstrual fluid flow are well preserved for standard laboratory cytological procedures. They are similar in appearance to cells collected by current clinical methods, and give similar reactions to chemicals and stains, and may be analyzed by the same procedures as cervical smears for PAP testing.